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Fr1da-/Fr1da-Plus-Study in Bavaria: Early Detection for Early Care of Type 1 Diabetes (Fr1da-Plus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04039945
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Information provided by (Responsible Party):
Anette-Gabriele Ziegler, Helmholtz Zentrum München

Brief Summary:
The Fr1da study aims to assess whether early staging of type 1 diabetes (1) is feasible at a population-based level, (2) prevents severe metabolic decompensation observed at the clinical manifestation of type 1 diabetes and (3) reduces psychological distress through preventive teaching and care.

Condition or disease
Type 1 Diabetes Mellitus

Detailed Description:

Type 1 diabetes can be diagnosed at an early presymptomatic stage by the detection of islet autoantibodies. Within the Fr1da-study, 100 000 children aged 1.75-5.99 years are tested for the presence of multiple islet autoantibodies. Screening is performed by primary care paediatricians. Islet autoantibodies are measured in capillary blood, and if positive, confirmed by venous blood in a second follow-up blood sample. Children with confirmed multiple islet autoantibodies are diagnosed with presymptomatic type 1 diabetes. These children and their parents are invited to participate in an education and counselling programme at a local diabetes centre. Depression and anxiety, and burden of early diagnosis are also assessed. The Fr1da-Plus-Study starts in 2019, after the enrollment of 100000 children into Fr1da, and extends screening to ages 9.0-10.99 years, and follows children with single islet autoantibodies for up to 3 years for progression to multiple islet autoantibody positivity.

The aims of the Fr1da- and Fr1da-Plus studies are:

  • to prevent life-threatening diabetic ketoacidosis at clinical onset of diabetes
  • to minimize psychological burden and uncertainty by training and intensive support of affected subjects
  • to evaluate feasibility of a comprehensive screening
  • to examine the prevalence of a pre-stage of Type 1 Diabetes
  • to assess geographic differences and association with environmental conditions for development of Type 1 Diabetes

The predefined criteria for the feasibility and clinical benefit of the study are >80% participation in the education and staging program, a diabetic ketoacidosis frequency of <5% in children with stage 3 diabetes, and <10% of parents with a Patient Health Questionnaire-9 (PHQ-9) sum score >15.

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Study Type : Observational
Estimated Enrollment : 180000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fr1da-/Fr1da-Plus-Study in Bavaria: Early Detection for Early Care of Type 1 Diabetes
Actual Study Start Date : February 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Primary Outcome Measures :
  1. presence of multiple islet autoantibodies [ Time Frame: up to 3 years ]
    multiple islet autoantibodies (IAA, GADA, IA-2A and/or ZnT8A)

Biospecimen Retention:   Samples Without DNA
blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children living in Bavaria at ages 1.75-5.99 years (U7 - U9) (Fr1da-study) and/or 9.0-10.99 years (U11)(Fr1da-Plus-Study)
children living in Bavaria with written informed consent by one custodial parent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04039945

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Contact: Anette-Gabriele Ziegler, +49 800-4648835

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Institut für Diabetesforschung, Helmholtz Zentrum München Recruiting
Munich, Germany
Contact: Anette-G. Ziegler,         
Sponsors and Collaborators
Helmholtz Zentrum München

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Responsible Party: Anette-Gabriele Ziegler, Prof. Anette-G. Ziegler, Director, Institute of Diabetes Research, Helmholtz Zentrum München Identifier: NCT04039945     History of Changes
Other Study ID Numbers: 808040014
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anette-Gabriele Ziegler, Helmholtz Zentrum München:
type 1 diabetes
islet autoantibodies
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases